- BBBH815326 May 10, 2022 Competitive
I am delighted to be collaborating with my client for an excellent opportunity as a Director of QP operations with a state of the art biologics facility based in Dublin.
This Biopharmaceutical company produce multiple therapies for the company's growing portfolio. The successful candidate will be responsible for supporting drug substance commercial and clinical operations and certifying finished drug product biologics in the EU and ROW markets.
For this role you will have at least 10 years of experience coming from the Pharma or Biopharma industry. You will be an eligible QP and experience acting as a QP in line with the EU guide to GMP. People management experience also essential for the role. Previous experience in biotech is desirable. A degree in science, engineering or a relevant discipline required.
- Lead a team of Qualified Persons and Quality Specialists responsible for release of Drug Substance on site and QP certification of commercial biologic products manufactured both internally and externally
- Manage batch certification process in accordance with the EudraLex - Volume 4 GMP Guidelines (Annex 16) for all commercial DP biologics released to the EU and ROW markets
- Responsible for Drug Substance release and associated processes at the site
- Represent the release function in internal, corporate, and regulatory inspections
- Collaborate with internal and external manufacturing to support supply of FDP biologics to markets in scope
- Ensure team has appropriate oversight of manufacturing, packing, and testing operations through effective management of quality agreements, change control and site visits as appropriate
- Lead escalation via Notification to Management (NTM) for significant issues discovered as part of certification activities
- Manage relationship across internal and external manufacturing stakeholders and brand teams
- Partner with disposition GPO/GPL and other certification/disposition teams in the network to ensure alignment and best practices for the operation
- Participate in the product recall process and Board of Health notification process
- Identify and recommend product and process quality improvements
- Provide representation, guidance, and leadership in process improvement initiatives globally and locally
- Responsible for hiring, coaching and development of staff
- Provide strategic planning and direct personnel to achieve operational goals and ensure the timely completion of tasks
If this role is of interest, please apply now.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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